Plasma Control Bi-Level 0041
by Chromsystems Instruments & Chemicals GmbH
Ref 0041
Plasma Control Bi-Level 0041 is a device classified as IVD General (EU), Class I (US) made by Chromsystems Instruments & Chemicals GmbH, registered in EUDAMED on 22 Sep 2026 (Basic UDI-DI B-04250317507440) and listed in FDA GUDID since 30 Jul 2020 (UDI-DI 04250317507440), active as of 23 Oct 2026.
Active
CE IVDD
Valid until
No date given
FDA recalls
Not checked
Documents
None linked in EUDAMED
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDD EUDAMED | NumberB-04250317507440 04250317507440 | Date22 Sep 2026 | StatusActive |
| United States | GUDID listing GUDID | Number04250317507440 | Date30 Jul 2020 | StatusListed |
Official records
- EUDAMED public site B-04250317507440
- AccessGUDID record 04250317507440
Across registries
- EUDAMED Basic UDI-DI B-04250317507440 registered 22 Sep 2026 Active
- FDA GUDID UDI-DI 04250317507440 listed 30 Jul 2020 Listed
Timeline
- Listed FDA GUDID 04250317507440
- Registered EUDAMED B-04250317507440
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
- European Union
- United States
Specification
- Trade name
- Plasma Control Bi-Level (I+II) EUDAMEDPlasma Control Bi-Level GUDID
- Generic name
- Mycophenolate therapeutic drug monitoring IVD, control
- Model / Ref / Catalog
- 0041
- Primary DI / UDI-DI
- 04250317507440
- Basic UDI-DI
- B-04250317507440
- FDA product code
- LAS
- EMDN code
- W0101050299 Specific controls (cc) - other
- GMDN term
- Mycophenolate therapeutic drug monitoring IVD, control
- Device class
- Class IVD General EUDAMEDClass I GUDID
- Regulation number
- 862.3280
- EU registration type
- Legacy device (under a directive)
- EU market of registration
- Germany
- GUDID distribution status
- In Commercial Distribution
Truth per registry
| Field | EUDAMED | GUDID |
|---|---|---|
| Device class | Class IVD General | Class I |
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